December 19, 2019

ACR Comments on Draft FDA Breast Implant Surveillance Guidance

A recent Food and Drug Administration (FDA) draft guidance “Breast Implants — Certain Labeling Recommendations to Improve Patient Communication” has prompted a response from the American College of Radiology® (ACR®), which recommends that the FDA consult the ACR’s Appropriateness Criteria® on Breast Implant Evaluation for guidance on post-implant imaging.

The ACR’s comments noted the draft guidance includes post-implant imaging recommendations that differ significantly from ACR recommendations, particularly in respect to proposing routine imaging surveillance of breast implants on an ongoing basis in asymptomatic women. Citing limited data and meta-analyses of several studies, the comments called into question the role of ultrasound and MRI without contrast in evaluation of silicone implants in asymptomatic patients.

Stamatia Destounis MD, FACR, represented the ACR as an FDA-invited speaker at a March 26, 2019, meeting of the FDA’s General and Plastic Surgery Devices Panel, where this topic was discussed.